Associate Director – Quality Assurance - Operational Readiness

About the role

We are looking for an Associate Director – Quality Assurance - Operational Readiness to ensure quality readiness of the Houston site as it transitions from project phase to GMP operations. This role provides end-to-end quality leadership to ensure that facilities, utilities, equipment, systems, processes, and teams are inspection-ready, compliant, and capable of sustained GMP execution at startup and beyond.

Responsibilities

• Define and drive the site Quality Operational Readiness strategy to ensure GMP compliance, inspection readiness, and successful regulatory approval.
• Partner with Project Management, Engineering, Operations, TSMS, Regulatory, and Global Quality to align quality readiness activities with project milestones and startup timelines.
• Establish and execute the site Quality Management Systems (e.g., deviations, change control, document management, training) to support initial licensure and sustainable operations.
• Identify, assess, and mitigate quality and compliance risks through structured risk assessments, readiness reviews, and escalation mechanisms.
• Define readiness metrics, dashboards, and governance routines to track progress and ensure accountability.
• Drive disciplined execution of quality deliverables across all startup phases.
• Support building and developing the site Quality organization through effective staffing, training, coaching, and knowledge transfer.
• Foster a strong “Safety First & Quality Always” mindset from project phase through commercial operations.

Requirements

• Bachelor’s degree in a scientific, engineering, or related discipline.
• 8+ years of experience in Quality within regulated GMP environments (Pharma, Biotech, or Medical Devices).
• Demonstrated experience supporting site startups, major expansions, or large capital projects from a Quality perspective.
• Strong working knowledge of GMP regulations, inspection readiness, validation, and quality systems.

Qualifications

• Prior experience in greenfield or brownfield manufacturing startups.
• Experience working with regulatory submissions, approvals, and pre-approval inspections.
• Strong understanding of aseptic manufacturing, utilities, equipment qualification, and data integrity principles (preferred for parenteral facilities).
• Proven ability to lead through ambiguity, manage competing priorities, and make risk-based quality decisions under time pressure.
• Excellent communication and stakeholder management skills, with the ability to influence across functions and levels.
• Collaborative leadership style with the ability to balance compliance, speed, and business needs.

Pay

The anticipated wage for this position is $123,000 - $180,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Schedule

This is a full-time position.